The following data is part of a premarket notification filed by Vitreq B.v. with the FDA for Vitreq Disposable Laser Probes, Light Fibers And Chandelier.
| Device ID | K182646 |
| 510k Number | K182646 |
| Device Name: | Vitreq Disposable Laser Probes, Light Fibers And Chandelier |
| Classification | Photocoagulator And Accessories |
| Applicant | Vitreq B.V. Segglant-Noord 2 Vierpolders, NL 3237mg |
| Contact | Jankees Wouts |
| Correspondent | Genci Omari Beaver-Visitec International, Inc. 500 Totten Pond Rd - 10 CityPoint Waltham, MA 02451 |
| Product Code | HQB |
| Subsequent Product Code | HQF |
| Subsequent Product Code | MPA |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-05-01 |